Senior Manager, IT Quality Assurance
At Genmab, we’re committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in science, we believe that being proudly unique, determined to be our best, and authentic is essential to fulfilling our purpose.
Genmab is focused on creating and developing innovative and differentiated antibody products, with the aim of improving the lives of cancer patients.
To support all the activities Genmab is looking to expand with a new IT QA Senior Manager.
As IT QA Senior Manager, you will contribute to establishing and maintaining the “Genmab Standard” for the oversight of computerized systems and be supporting several IT validation projects.
You will be part of a global QA team and report to the Team Lead IT QA. This role will be based out of our Utrecht, NL Office.
The responsibilities of the IT QA Senior Manager will include, but are not limited to:
- Ensuring compliance with applicable regulatory requirements of the computerized systems that are or will be implemented
- Quality oversight, review, and approval of validation processes and validation activities performed in Genmab across the regulated parts of the organization
- Identifying and implementing improvements to the IT system life cycle and validation processes to ensure a pragmatic and risk-based validation approach
- Support IT in establishing and maintaining an IT infrastructure qualified for intended use i.e. in supporting validated systems.
- Securing compliance with internal procedures and external GxP demands
- Preparing computerized system risk and regulatory impact assessments and other evaluations, e.g. periodic reviews
- Coordinating validation activities in compliance with corporate policy, local procedures, and regulatory expectations.
- Reviewing and assisting in developing departmental standard operating procedures (SOPs) and validation programs
- Supporting vendor qualification activities
- Supporting infrastructure qualification/computerized system validation projects as allocated
- 5-10 years of IT QA Management experience within the Life Science industry
- Documented experience with implementing and validating IT systems, as well as supporting and maintaining existing IT systems keeping them in a validated state
- Experience with cloud-based software, internally hosted systems, and qualification of IT infrastructure, e.g. as part of an ITIL program
- A Degree preferably in Natural Science combined with an IT education.
- Excellent English communication skills, both written and spoken
Genmab will offer the successful application a challenging position, where the right candidate will have the opportunity to work with highly specialized people across functions in an informal, multicultural environment, with an aim to make a difference in the lives of people with cancer.
At Genmab, we pride ourselves on our unique culture. We are committed to making a positive impact on the lives of cancer patients. We hypothesize and experiment to seek innovative solutions, no matter the employee’s role; we speak up, empower each other, and embrace change and growth; we respect and celebrate our differences while working as one team.
Teamwork and respect are central pillars of Genmab’s culture and we, therefore, ensure an inclusive, open, and supportive professional work environment across our international locations. Genmab employees work with determination, challenge the status quo, and cultivate a growth mindset in everything we do.
We are committed to fostering workplace diversity at all levels of the company and we believe it is essential for our continued success. No applicant shall be discriminated against or treated unfairly because of their race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, disability, or genetic information.
- You are passionate about our purpose and genuinely care about our mission to transform the lives of patients through innovative cancer treatment
- You bring rigor and excellence to all that you do. You are a fierce believer in our rooted-in-science approach to problem-solving
- You are a generous collaborator who can work in teams with diverse backgrounds
- You are determined to do and be your best and take pride in enabling the best work of others on the team
- You are not afraid to grapple with the unknown and be innovative
- You have experience working in a fast-growing, dynamic company (or a strong desire to)
- You work hard and are not afraid to have a little fun while you do so
Genmab leverages the effectiveness of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are designed as open, community-based spaces that work to connect employees while being immersed in our state-of-the-art laboratories. Whether you’re in one of our collaboratively designed office spaces or working remotely, we thrive on connecting with each other to innovate.
Founded in 1999 in Copenhagen, Denmark, Genmab is an innovative biotech company that has become a leader in antibody biology and innovation. Our product pipeline and next-generation antibody technologies are the result of our strong company culture, a deep passion for innovation, and desire to transform cancer treatment and serious diseases.
When you work with us, you’ll be part of a warm, fun, dynamic community, and team up with some of the best, most authentic individuals in locations around the world, who care deeply and share in a relentless drive to innovate and create transformational medicines. People who are candid, impact-driven, and a little unconventional; who seek out and embrace the opportunity to build new and bold futures within a rapidly growing and innovative biotech company; who bring their full selves to work and show up for each other - rolling up their sleeves to get the job done. This translates into a place where you can be authentically you; are empowered to innovate, build solutions, and execute; feel cared for and supported in growth; and are a critical part of changing the lives of patients around the world through transformative cancer treatment.
Our commitment to diversity, equity, and inclusion
We are committed to fostering workplace diversity at all levels of the company and we believe it is essential for our continued success. No applicant shall be discriminated against or treated unfairly because of their race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, disability, or genetic information. Learn more about our commitments on our website .
Please note that if you are applying for a position in the Netherlands, Genmab’s policy for all permanently budgeted hires in NL is initially to offer a fixed-term employment contract for a year, if the employee performs well and if the business conditions do not change, renewal for an indefinite term may be considered after the fixed-term employment contract.